Kornimate/medical-research-clean huggingface dataset:
distraction techniques in periocular anesthesia: tapping vs vibration

Conditions: Anesthetics, Local; Blepharoplasty; Age-Related Ptosis; Adult; Humans; Lidocaine; Ophthalmologic Surgical Procedure; Vibration; Surgery

Summary: to compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections.

participants will be selected from 3 local oculoplastics surgeons' procedural slates during the study period. eligible participants are those who will be undergoing bilateral eye procedures. they will be randomized into one of two groups: group a will receive tapping on their forehead for their first eye injection of local anesthesia, and then vibration to their forehead for the second eye. group b will receive the reverse. pain scores will be aggregated and an average taken to help determine which method is superior. the vibration assist device (variety of facial massagers are available on amazon for roughly $16-20cdn) is being considered in addition to the current standard of tapping or no tactile distraction at all during the injection of local anesthetic. the 11-point pain visual analog scale will be used to help grade pain experience after each eye is frozen. to help qualify, if there is a difference, the patient will be asked if they felt one technique was better than the other by a little, quite a bit, or a lot.

Eligibility criteria:
inclusion criteria: * adult patients undergoing elective bilateral eye procedures such as blepharoplasty exclusion criteria: * previous eyelid surgery * inability to give consent

Keywords: study, crossover pain measurement prospective study
effect of low level laser therapy in patients with chronic rhinosinusitis.

Conditions: Rhinosinusitis; Headache; Fatigue; CT

Summary: this study aimed to evaluate the efficacy of low-level laser therapy (lllt) for chronic sinusitis in a randomized, double-blind, placebo-controlled trial.

chronic sinusitis, or chronic rhinosinusitis, is an inflammatory condition defined by symptomatic inflammation of the paranasal sinuses lasting longer than 3 months. common presenting symptoms include nasal obstruction, facial pressure or fullness, nasal discharge (anterior or posterior), and olfactory loss. furthermore, chronic sinusitis is associated with reductions in patient quality of life (qol), sleep quality, and daily productivity. it has been suggested that low-level laser can be used in treating chronic sinusitis but there are limited studies about its usage. hypotheses: there is no statistically significant effect of laser therapy on headache, fatigue, or ct finding in patients with chronic sinusitis.

Eligibility criteria:
inclusion criteria: * patients suffering from mild to moderate symptoms. exclusion criteria: * pregnant or breastfeeding women * patients with a definite deviated nasal septum, sinusitis, or history of operation within the last 6 months. * patients with hypertension, diabetes mellitus, malignancy, active pulmonary tuberculosis, infection, active respiratory disease like asthma, or other systemic diseases; • patients with long-term use of corticosteroids or immunosuppressive agents. * patients with hypersensitivity to the laser. * patients who were involved in another clinical study within 30 days. * patients who were unable to comply with the follow-up schedules. * patients who had used antihistamines within 1 week, topical corticosteroids within2 weeks, systemic corticosteroids within 4 weeks, anti-cholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, non-steroidal analgesics within 2 weeks, and other drugs whi
salt diet and various biomarkers effects on blood pressure and proteinuria during inhibition of vegf)

Conditions: Patient Starting Bevacizumab; Cancer

Summary: bevacizumab is an anti-angiogenic treatment used to treat various solid cancers. previous studies have shown that this treatment may have adverse effects like hypertension and proteinuria. this is an exploratory study aiming to better understand the relationship between various biomarkers and blood pressure changes and proteinuria measured for 4 to 6 weeks after the first infusion of anti-vegf therapy with bevacizumab.

participants will be invited to participate to this research study by their oncologist within 1 to 2 weeks before starting bevacizumab treatment, as part of standard treatment. they will finish the research at the end of the third infusion of bevacizumab. patients will perform a home blood pressure self-measurement over three days and will collect urine over 24 hours prior to the start of each bevacizumab infusion at cycles 1, 2 and 3. blood pressure measurements will also be performed during each bevacizumab infusion and blood tests will be performed before each infusion to measure the following biomarkers: * salt consumption as estimated by 24-hour natriuresis measured before each of the first 3 infusions * 24 hours aldosterone excretion measured before the first and third infusions * plasma methoxylated derivatives measured before the first and third infusions * ntprobnp measured before the first and third infusions * 24 hours urinary free cortisol measured before the first and third infusions * bevacizumab trough concentration measured before the first three bevacizumab infusion

Eligibility criteria:
inclusion criteria: * adult patient * with a solid cancer for which a treatment with bevacizumab (avastin®) is indicated in accordance with its marketing authorization exclusion criteria: * renal cancer * recent changes in antihypertensive treatment(s) in the last month, with the exception for diuretics where treatment stability of at least 3 months will be required * patients who do not wish to participate to the study

Keywords: cancer bevacizumab blood pressure proteinuria
laparoscopic surgery versus radiofrequency ablation for recurrent hcc

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is the fifth most common and the third leading cause of death from cancer worldwide1 . hepatectomy is still the main effective treatment for hcc accompanying with well-preserved cirrhosis when liver transplantation is not feasible due to the lack of donors recurrence of tumor within the liver remnant is also common, with a reported 5-year recurrence rate of 50-70%, in patients who have undergone "curative" hepatectomy. management of recurrent hcc is still urgent and several treatments have been developed. repeat hepatectomy is considered to be the first choice for recurrent hcc with a 5-year survival rate of 19.4 to 56%. unfortunately, repeat hepatectomy can be performed only in a small proportion of patients with hcc recurrence due to the poor functional liver reserve or because of widespread recurrence. with a 3-year survival rate of 62% to 68% after treatment, radiofreqency ablation (rfa) has been used as an effective treatment for recurrent hcc. the efficacy of rfa for recurrent hcc has been reported to be comparable to those achieved by surgery. laparoscopic surgery was considered not to be a suitable treatment for recurrent hcc due to postoperative adhesions that can make laparoscopic surgical procedure more difficult and less safe. recently, several studies reported that laparoscopic surgery for recurrent hcc in cirrhotic patients is a safe and feasible procedure with good short-term outcomes. by far, no study has been performed to compare the efficacy and safety of laparoscopic surgery with rfa for treatment of recurrent hcc.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years; 2. recurrent hcc after curative partial hepatectomy; 3. no other treatment received except for partial hepatectomy; 4. a solitary recurrent hcc ≤ 5.0 cm in diameter, or multiple recurrent hcc ≤ 3 lesions, each ≤ 3.0 cm in diameter; 5. no radiologic evidence of invasion into major portal/ hepatic vein branches ; 6. no extrahepatic metastases; 7. child-pugh class a or b liver cirrhosis; 8. american society of anesthesiologists (asa) score ≤ 3; 9. eastern co-operative oncology group performance (ecog) status 0; exclusion criteria: 1. coagulation disorders (prothrombin activity \<40% or a platelet count of \<80,000/mm3); 2. child-pugh class c liver cirrhosis; 3. history of hepatic encephalopathy, ascites refractory to diuretics or esophageal or gastric variceal bleeding; 4. a history of a secondary malignancy; 5. active infection (except viral hepatitis); 6. severe dysfunction of the heart, kidney, or other organs
plx2853 in combination with abiraterone acetate and prednisone and in combination with olaparib in subjects with metastatic castration-resistant prostate cancer (mcrpc)

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug plx2853 in subjects with metastatic castration-resistant prostate cancer (mcrpc)


Eligibility criteria:
inclusion criteria: 1. age ≥18 years at the time of signing informed consent. 2. histologically confirmed adenocarcinoma of the prostate with tumor tissue available for molecular analyses. 3. eastern cooperative oncology group performance status 0 to 1. 4. adequate organ function as demonstrated following laboratory values. 5. fertile male subjects with female sexual partners must agree to use a highly effective method of birth control during the study and for 90 days after the last dose of study drug. 6. except as specified above for organ function, all drug-related toxicity from previous cancer therapy (including ongoing abiraterone acetate + prednisone therapy if applicable) must be resolved (to grade ≤1 or baseline per national cancer institute common terminology criteria for adverse events version 5.0) prior to study treatment administration (grade 2: alopecia, hot flashes, decreased libido, or neuropathy is allowed). 7. willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements. exclusion criteria: 1. prior exposure to a bromodomain inhibitor. 2. history of autoimmune hemolytic anemia or autoimmune thrombocytopenia. 3. clinically significant cardiac disease. 4. inability to take oral medication or significant nausea and vomiting, malabsorption, or significant small bowel resection that, in the opinion of the investigator, would preclude adequate absorption. 5. active known second malignancy with the exception of any of the following: * adequately treated basal cell carcinoma or squamous cell carcinoma of the skin. * adequately treated stage i cancer from which the subject is currently in remission and has been in remission for ≥2 years. * any other cancer from which the subject has been disease-free for ≥3 years. 6. subject is participating in any other therapeutic clinical study (observational or registry studies are allowed). 7. presence of any other medical, psychological, familial, sociological, or geographic condition potentially hampering compliance with the study protocol or would interfere with the study endpoints or the subject's ability to participate in the study in the judgment of the investigator. 8. receipt of any anti-cancer therapy prior to cycle 1 day 1 with less than protocol defined wash-out with the exception of abiraterone acetate (for subjects enrolling into abiraterone acetate combination) and gnrh therapy.

Keywords: plx2853 metastatic castration-resistant prostate cancer olaparib abiraterone acetate adenocarcinoma prostate cancer
does cyclosporine improve clinical outcome in st elevation myocardial infarction patients at 3 years of follow-up. circus ii study

Conditions: ST Elevation Acute Myocardial Infarction

Summary: infarct size is a major determinant of vital prognosis after ami. we recently reported that cyclosporine a, when administered immediately prior to pci reperfusion, can significantly reduce infarct size in stemi patients. the circus study aimed at determining the impact of cyclosporine on the combined incidence of (death, hospitalization for heart failure, lv remodelling) at one year after ami. however, many patients may display increased adverse lv remodelling beyond year 1 and develop heart failure thereafter. the present circus ii trial aims at examining the 3-year clinical outcome of all patients recruited in the circus study.


Eligibility criteria:
inclusion criteria: * all (male and female) patients, aged over 18, without any legal protection measure, * having a health coverage, * presenting within 12 hours of the onset of chest pain, * who have st segment elevation ≥0.2 mv in two contiguous leads, * for whom the clinical decision was made to treat with percutaneous coronary intervention (pci). and (further inclusion criteria to be confirmed by the admission coronary-angiography): * the culprit coronary artery has to be the lad * the lad artery has to be occluded (timi flow grade 0-1) at the time of admission coronary angiography. * preliminary oral informed consent followed by signed informed consent as soon as possible. patients undergoing either primary pci or rescue pci are eligible for the study. patients with previous ami, pci or coronary artery bypass surgery (cabg) are eligible for the study. exclusion criteria: * patients with loss of consciousness or confused * patients with cardiogenic shock * patients with the left circumflex or the right coronary artery (rca) as the culprit artery, or with evidence of coronary collaterals to the risk region * patients with an opened (timi \> 1) lad coronary artery at admission on initial (admission) coronary angiography * patients with 1. known hypersensitivity to cyclosporine 2. known hypersensitivity to egg, peanut or soya-bean proteins 3. known renal insufficiency (either known creatinin clearance \ 180/110 mmhg) * patients treated with any compound containing hypericum perforatum (st.-john's-worth) or stiripentol or aliskiren or bosentan or rosuvastatine * female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis). * patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation 1. cancer, lymphoma 2. known positive serology for hiv, or hepatitis
study on the incidence of febrile episodes during stem cells collection after chemotherapy in patients with multiple myeloma

Conditions: G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim

Summary: to evaluate the difference in the incidence of febrile episodes in patients undergoing stem cells mobilization with chemotherapy and filgrastim versus chemotherapy and lenograstim. a febrile episode will be considered as: body temperature \> 38°c for two measurements in the 24 hours with an interval of 6 hours at least between the two measurements.


Eligibility criteria:
inclusion criteria: 1. age \> 18 and \< 70 years 2. diagnosis of multiple myeloma 3. ecog \< 2 to be evaluated at baseline, after the induction chemotherapy 4. indication to the mobilization with high dose cyclophosphamide chemotherapy 5. normal blood counts: neutrophils \> 1500/μl; platelets \> 100.000/μl; hemoglobin \> 10 g/dl. 6. liver and renal function: sgot/ast, sgpt/alt; bilirubin \< 1.5 times the upper limit of the normal ranges; creatinine \< 2 times the upper limit of the normal ranges. 7. interval from previous induction chemotherapy to high dose chemotherapy between 30 and 60 days 8. ecg e/o echocardiogram within age related normal range 9. negative hcv and hbsag 10. must be willing and able to fill in the patient's diary 11. written informed consent exclusion criteria: 1. documented and/or suspected infections 2. uncontrolled concurrent illness 3. documented cardiac dysfunction
adhd: gaps between patients with alcohol-dependence and impact on relapse

Conditions: Alcoholism; Attention Deficit Disorder With Hyperactivity

Summary: some recent studies have found that adult attention deficit - hyperactivity disorder (adhd) was frequent among patients with alcohol-dependence. however, no investigation has ever addressed whether adhd may impact the drinking outcome. moreover, most of the different aforementioned studies assessed adhd using the adhd self-report scale (asrs). the asrs is a screening questionnaire that is of limited diagnostic value, and the overrepresentation of high-score asrs among patients with alcohol-dependence could be in part due to differential diagnoses such as antisocial or borderline personality disorders, executive function impairments, or isolated impulsiveness. the study aims to evaluate "adhd: gaps between patients with alcohol dependence and impact on early relapse" (agadir). in agadir, subjects with alcohol-dependence are recruited at the end of a residential detoxification program. they are assessed for adhd using the asrs, but also with a standardized diagnostic tool, i.e., the diagnostic interview for adhd in adults (diva 2.0). potential differential diagnoses are screened during the baseline visit. the patients are followed-up during the 12 first post-detox weeks, through a standardized psychosocial treatment. asrs is re-performed at the end of the follow-up.


Eligibility criteria:
inclusion criteria: * current dsm-iv-tr criteria for alcohol-dependence * current residential alcohol detoxification program non-inclusion criteria: * concurrent alcohol withdrawal symptoms, i.e., ciwa-ar ≥ 10 * benzodiazepine diazepam-equivalent dose \> 30 mg * medical history of neurological impairment (excluding alcohol-induced cognitive disorders) * guardianship or loss of liberty * pregnant or lactating woman

Keywords: attention deficit disorder with hyperactivity alcohol dependence adults treatment outcome mental health
pressure support and positive end expiratory pressure during spontaneous breathing trial

Conditions: Critically Ill Adult Patients With Difficult Weaning

Summary: the aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by t-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients.


Eligibility criteria:
inclusion criteria: * patient 18 years old or more * intubated and ventilated in intensive care unit for more than 24 hours * patient ready for weaning evaluation * failure of a first t-piece sbt exclusion criteria: * chronic neuromuscular disease * guillain-barré syndrome * central nervous system disease with consciousness disorder * tracheostomy * chronic disease with life expectancy less than 1 year * pregnancy, breast feeding * withholding life support regarding a reintubation * prisoner or patient interned in psychiatric hospital * guardianship * language barrier * lack of medical insurance * lack of the patient's consent (or of the next of kin where appropriate) * patient under an exclusion period after enrollment in another research study

Keywords: critical care spontaneous breathing trial t-piece positive end-expiratory pressure difficult weaning
rankl inhibition and breast tissue biomarkers

Conditions: Breast Cancer Prevention; Mammographic Density

Summary: a robust knowledge of how to reduce breast density could play a key role in breast cancer prevention in premenopausal women, but viable preventative targets to reduce breast density-associated breast cancer risk are yet to be developed. the investigators propose to investigate the effect of rankl inhibition with denosumab on breast tissue markers in high-risk premenopausal women with dense breasts. study findings could provide robust evidence to move forward with a clinical trial targeting rankl inhibition in premenopausal breast cancer prevention.


Eligibility criteria:
inclusion criteria: * female. * premenopausal. * at least 35 years of age. * dense breasts on routine mammogram. * willing to take calcium (1,200mg) and vitamin d (800 iu) daily. * at increased risk for breast cancer using any of the following: * positive family history of breast cancer * breast cancer risk prediction models * able and willing to return for repeat biopsy. * able to understand and willing to sign an irb-approved written informed consent document. exclusion criteria: * current use of tamoxifen, aromatase inhibitors, or bisphosphonates. * concurrently participating in another cancer chemoprevention trial (unless no longer receiving the intervention). * pregnant or lactating. * recent tooth extraction or dental procedure. * unhealed and/or planned dental/oral surgery. * history of osteonecrosis/osteomyelitis of the jaw. * history of osteoporosis or severe osteopenia. * unable/unwilling to return for repeat biopsy.

Keywords: mammographic density premenopausal breast cancer chemoprevention denosumab
study effect of via-2291 on atherosclerotic vascular inflammation in patients undergoing elective carotid endarterectomy

Conditions: Atherosclerosis

Summary: this is a study to compare the effect of via-2291 vs. placebo on various inflammatory biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy


Eligibility criteria:
inclusion criteria: * female patients must be of non-childbearing potential * carotid stenosis between 60% and 90% and to be scheduled for cea surgery * one or more of the following clinical features: prior history \>4 weeks of cerebrovascular accident (cva) or transient ischemic attack (tia) consistent with north american symptomatic carotid endarterectomy trial (nascet) criteria or prior history of amaurosis fugax occurring at any time * diabetes haemoglobin (hb) a1c between 7.0 and 11% or a history of two or more fasting blood glucose levels \>6.9 mmol/l * baseline hscrp \>2 mg/l * echolucent plaque exclusion criteria: * acute cva or tia within 4 weeks of enrollment or the presence of ulcerated or unstable plaque requiring urgent carotid endarterectomy * renal insufficiency defined as creatinine \>1.5 x upper limit of normal (uln) * cirrhosis, recent hepatitis, alanine aminotransferase (alt) \>1 x uln (i.e., above the normal range) or positive screening test for hepatitis b (hepatitis b surface antigen) or hepatitis c (by elisa) * uncontrolled diabetes mellitus within 1 month prior to study screening, defined as hba1c \>11% at screening * congestive heart failure (chf) defined by the new york heart association as functional class iii or iv * recent acute coronary syndrome event or coronary artery bypass graft (cabg) surgery (within 4 weeks of enrollment) * current atrial fibrillation * planned cardiac intervention * acetaminophen use in any form in the 7 days before enrollment